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NCQA has helped to build consensus around important health care quality issues by working with large employers, policymakers, doctors, patients and health plans to decide what’s important, how to measure it, and how to promote improvement. That consensus is invaluable — transforming our health care system requires the collected will and resources of all these constituencies and more.
Thursday, June 17, 2010
TYELNOL RECALL
June 15, 2010
Dear Healthcare Professional:
I am writing to inform you that McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling five product lots as an addition to the list of products included in the company's January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count, sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is being conducted with the knowledge of the U.S Food and Drug Administration. McNeil is providing the following information to consumers on the www.mcneilproductrecall.com Web site.
MCNEIL CONSUMER HEALTHCARE RECALLS FOUR PRODUCT LOTS OF BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 COUNT, AND ONE PRODUCT LOT OF EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS, 50 COUNT
Fort Washington, PA (June 15, 2010) - McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company's January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count, sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All of these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.
BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.
The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.
Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Requests for reimbursement can be made at www.mcneilproductrecall.com. Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/safety/medwatch/default.htm.
The product lot numbers for the recalled products can be found on the side of the bottle label.
If you have any questions yourself, please call our Medical Affairs Department at 1-866-948-6883 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time) or visit our dedicated Web site for Healthcare Professionals at TylenolProfessional.com.
Sincerely,
Edwin K. Kuffner, MD
Vice President, Medical Affairs
McNeil Consumer Healthcare
FULL RECALLED PRODUCT LIST:
Product Code Product Name Lot Number UPC Code
TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAPS
4885000 TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAPS 50 ct
BENADRYL® ALLERGY ULTRATAB™ TABLETS
1703302 BENADRYL® ALLERGY ULTRATAB™ Tablets 100 ct
You are receiving this email because you have opted-in to receive communications from McNeil Consumer Healthcare. Please do not respond to this email, since it is not enabled to process responses. If you have any questions, email us or call us at 1-866-948-6883, Monday through Friday, 9 am to 4:30 pm EST. Also, please add info@TylenolProfessional.com to your address book or email safelist so that future emails from us can reach you.
If you do not wish to receive future communications from TylenolProfessional.com, you can unsubscribe.
7050 Camp Hill Road
Fort Washington, PA 19034, USA
©McNEIL-PPC, Inc. 2010
Dear Healthcare Professional:
I am writing to inform you that McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling five product lots as an addition to the list of products included in the company's January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count, sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is being conducted with the knowledge of the U.S Food and Drug Administration. McNeil is providing the following information to consumers on the www.mcneilproductrecall.com Web site.
MCNEIL CONSUMER HEALTHCARE RECALLS FOUR PRODUCT LOTS OF BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 COUNT, AND ONE PRODUCT LOT OF EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS, 50 COUNT
Fort Washington, PA (June 15, 2010) - McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company's January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count, sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All of these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.
BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.
The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.
Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Requests for reimbursement can be made at www.mcneilproductrecall.com. Consumers who have medical concerns or questions should contact their healthcare provider.
Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/safety/medwatch/default.htm.
The product lot numbers for the recalled products can be found on the side of the bottle label.
If you have any questions yourself, please call our Medical Affairs Department at 1-866-948-6883 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time) or visit our dedicated Web site for Healthcare Professionals at TylenolProfessional.com.
Sincerely,
Edwin K. Kuffner, MD
Vice President, Medical Affairs
McNeil Consumer Healthcare
FULL RECALLED PRODUCT LIST:
Product Code Product Name Lot Number UPC Code
TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAPS
4885000 TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAPS 50 ct
BENADRYL® ALLERGY ULTRATAB™ TABLETS
1703302 BENADRYL® ALLERGY ULTRATAB™ Tablets 100 ct
You are receiving this email because you have opted-in to receive communications from McNeil Consumer Healthcare. Please do not respond to this email, since it is not enabled to process responses. If you have any questions, email us or call us at 1-866-948-6883, Monday through Friday, 9 am to 4:30 pm EST. Also, please add info@TylenolProfessional.com to your address book or email safelist so that future emails from us can reach you.
If you do not wish to receive future communications from TylenolProfessional.com, you can unsubscribe.
7050 Camp Hill Road
Fort Washington, PA 19034, USA
©McNEIL-PPC, Inc. 2010
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